Breast CarcinomaNCT07606287
Studying the Workflow of the American College of Surgeons Geriatric Surgery Program to Improve Clinical Outcomes in Older Adults Undergoing Surgery at the James Cancer Hospital
A study testing Serious Illness Conversation Program training and ACS Geriatric Surgery Verification Program Implementation in people with Breast Carcinoma and Malignant Digestive System Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study examines how the American College of Surgeons Geriatric Surgery Verification Program, also called the ACS GSV Program, is implemented at the James Cancer Hospital. The program is designed to improve surgical care for adults age 65 and older by helping care teams identify and address age-related needs… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
- What is being tested?
- Serious Illness Conversation Program training and ACS Geriatric Surgery Verification Program Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient records for adults aged 65 years or older
- Patient records with a surgical encounter or preoperative evaluation within participating James Cancer Hospital surgical oncology services during the rollout period
- Patient records with data available in institutional electronic health record or institutional data systems
- Clinical staff age 18 years or older who are employed or credentialed at The Ohio State University Wexner Medical Center and work within clinical areas affected by ACS Geriatric Surgery Verification implementation
Who cannot join
- Patient records for encounters occurring only at outside institutions or non-James hospitals within the enterprise
- Patient records missing all primary outcome fields after data quality checks
- Clinical staff who are trainees, including medical students, physician assistant students, nursing students, resident physicians, or fellows
- Clinical staff whose employment, visa, or institutional status would make participation sensitive under institutional policy, if applicable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Samilia Obeng-Gyasi, MD, MPH, 812-361-6787, Samilia.Obeng-Gyasi@osumc.edu
Samilia Obeng-Gyasi, MD, MPH
About this study
Official title: Implementation of the American College of Surgeons Geriatric Surgery Verification Program at the James Cancer Hospital
This study examines how the American College of Surgeons Geriatric Surgery Verification Program, also called the ACS GSV Program, is implemented at the James Cancer Hospital. The program is designed to improve surgical care for adults age 65 and older by helping care teams identify and address age-related needs before, during, and after surgery.
Older adults with cancer may have concerns related to physical function, memory or thinking, medications, social support, and goals of care. If these needs are not recognized, patients may be at higher risk for complications, longer hospital stays, readmission, or discharge to a facility instead of home.
Read more
The ACS GSV Program includes standards for geriatric surgery leadership, goals-of-care discussions, screening for age-related vulnerabilities, care plans for identified needs, age-friendly perioperative care, and regular review of surgical outcomes. This study will evaluate how well these standards are adopted across surgical oncology services and whether implementation is associated with better outcomes, such as shorter hospital stays, fewer complications, fewer readmissions, and improved discharge outcomes.
The results may help improve surgical care workflows for older adults undergoing cancer surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine adoption, fidelity, sustainability, acceptability, and appropriateness/feasibility of implementing the American College of Surgeons Geriatric Surgery Verification (ACS GSV) Program at the James Cancer Hospital.
II. To compare clinical outcomes before and after ACS GSV implementation at the James Cancer Hospital.
SECONDARY OBJECTIVES:
- To estimate the costs and incremental cost effectiveness of implementing each of the six ACS GSV standards.
II. To develop and validate a Geriatric Surgery Verification (GSV) fidelity index and examine dose response relationships with patient outcomes.
III. To use the Capability, Opportunity, Motivation-Behavior (COM-B) model paired with the Theoretical Domains Framework (TDF) to identify determinants of referrals to the Cancer and Aging Resiliency (CARE) clinic and also to determine the use of the GSV goals of care dot phrase among surgeons.
OUTLINE: Surgical services are randomized to 1 of 3 groups and participants are assigned to the group to which their service was randomized.
GROUP 1: Participants complete the Serious Illness Conversation Program (SICP) over two months (months 1-2). Participants then implement the ACS GSV program into surgical services over four months (months 3-6) followed by a transition period over 1 month (month 7) and continued maintenance implementation of the ACS GSV program over 9 months (months 8-16).
GROUP 2: Participants complete the SICP workshop over two months (months 6-7). Participants then implement the ACS GSV program into surgical services over four months (months 8-11) followed by a transition period over 1 month (month 12) and continued maintenance implementation of the ACS GSV program over 4 months (months 13-16).
GROUP 3: Participants complete the SICP workshop over two months (months 11-12). Participants then implement the ACS GSV program into surgical services over four months (months 13-16).
- Conditions
- Breast Carcinoma, Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Genitourinary System Neoplasm, Malignant Head and Neck Neoplasm, Malignant Nervous System Neoplasm
- Being tested
- Serious Illness Conversation Program training, ACS Geriatric Surgery Verification Program Implementation
- Keywords
- geriatric surgery verification, oncogeriatrics
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms, Urogenital Neoplasms, Head and Neck Neoplasms, Skin Neoplasms, Soft Tissue Neoplasms, Central Nervous System Neoplasms, Endocrine Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious Illness Conversation Program trainingBehavioural
Surgeons and advanced practice providers complete Serious Illness Conversation Program training to support elicitation and documentation of goals of care for older adults undergoing oncologic surgery.
ACS Geriatric Surgery Verification Program ImplementationOther
Also called GSV implementation
Implementation of the American College of Surgeons Geriatric Surgery Verification Age-Friendly Level standards across surgical oncology services, supported by tailored implementation strategies informed by the Capability, Opportunity, Motivation-Behavior model, Theoretical Domains Framework, and Behavior Change Wheel. Components include goals-of-care documentation workflows, G8 geriatric vulnerability screening, referral pathways for patients with positive screens, age-friendly perioperative care processes, and data surveillance/quality monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (months 3-6 ACS GSV) | Experimental | Participants complete the Serious Illness Conversation Program (SICP) workshop over two months (months 1-2). Participants then implement the ACS GSV program into surgical services over four months (months 3-6) followed by a transition period over 1 month (month 7) and continued maintenance implementation of the ACS GSV program over 9 months (months 8-16). Receives: Behavioral: Serious Illness Conversation Program training; Other: ACS Geriatric Surgery Verification Program Implementation |
| Group 2 (months 8-11 ACS GSV) | Experimental | Participants complete the SICP workshop over two months (months 6-7). Participants then implement the ACS GSV program into surgical services over four months (months 8-11) followed by a transition period over 1 month (month 12) and continued maintenance implementation of the ACS GSV program over 4 months (months 13-16). Receives: Behavioral: Serious Illness Conversation Program training; Other: ACS Geriatric Surgery Verification Program Implementation |
| Group 3 (months 13-16 ACS GSV) | Experimental | Participants complete the SICP workshop over two months (months 11-12). Participants then implement the ACS GSV program into surgical services over four months (months 13-16). Receives: Behavioral: Serious Illness Conversation Program training; Other: ACS Geriatric Surgery Verification Program Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of the Core ACS GSV Care Bundle
Patient-level completion of the core ACS GSV care bundle, defined as completed goals-of-care documentation, completed G8 geriatric vulnerability screening, and, among patients with a positive G8 screen, documented referral to the Cancer Aging and Resiliency Clinic or documented rationale for referral deferral.
Measured as the percentage of eligible patients who complete the core ACS GSV care bundle. The bundle is defined as completed goals-of-care documentation, completed G8 geriatric vulnerability screening, and, among patients with a positive G8 screen, documented referral to the Cancer Aging and Resiliency Clinic or documented rationale for referral deferral.
Measured: From ACS GSV implementation through study completion, up to 3 years.
Hospital Length of Stay
Patient hospital length of stay after surgery, measured in days using electronic health record data.Measured in days from admission to discharge for the index surgical hospitalization using electronic health record data.
Measured: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
Secondary outcomes (12)
Completion of Goals-of-Care Documentation
Percentage of eligible patients with completed goals-of-care documentation in the electronic health record using the institutional goals-of-care documentation workflow.
Measured: From ACS GSV implementation through study completion, up to 3 years.
Completion of G8 Geriatric Vulnerability Screening
Percentage of eligible patients who complete G8 geriatric vulnerability screening as part of the ACS GSV implementation workflow.
Measured: From ACS GSV implementation through study completion, up to 3 years.
Implementation Cost
Cost of ACS GSV implementation estimated using a micro-costing approach, including personnel time, training, workflow development, electronic health record optimization, and other implementation-related resources.
Measured: From pre-implementation planning through study completion, up to 3 years.
Referral or Documented Deferral for Positive G8 Screens
Among patients with a positive G8 screen, percentage with documented referral to the Cancer Aging and Resiliency Clinic or documented rationale for referral deferral.
Measured: From ACS GSV implementation through study completion, up to 3 years.
ACS GSV Fidelity Index Score
Composite fidelity score based on a structured checklist mapped to ACS GSV Standards 2 through 5. Checklist elements are coded as present or absent, weighted by clinical importance, and scaled from 0 to 100, with higher scores indicating greater fidelity to ACS GSV implementation.
Measured as a composite fidelity score on a 0 to 100 scale, with higher scores indicating greater fidelity to ACS GSV implementation. The score is based on a structured checklist mapped to ACS GSV Standards 2 through 5. Checklist elements are coded as present or absent and weighted by clinical importance.
Measured: From ACS GSV implementation through study completion, up to 3 years.
Acceptability of ACS GSV Implementation
Clinician and staff acceptability of ACS GSV implementation measured using the Acceptability of Intervention Measure. Higher scores indicate greater perceived acceptability.
Measured using the Acceptability of Intervention Measure, a validated four-item implementation outcome instrument. Scores range from 1 to 5, with higher scores indicating greater perceived acceptability among clinicians and staff.
Measured: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
Appropriateness of ACS GSV Implementation
Clinician and staff perceived appropriateness of ACS GSV implementation measured using the Intervention Appropriateness Measure. Higher scores indicate greater perceived appropriateness. Measured using the Intervention Appropriateness Measure, a validated four-item implementation outcome instrument. Scores range from 1 to 5, with higher scores indicating greater perceived appropriateness among clinicians and staff.
Measured: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
Feasibility of ACS GSV Implementation
Clinician and staff perceived feasibility of ACS GSV implementation measured using the Feasibility of Intervention Measure. Higher scores indicate greater perceived feasibility. Measured using the Feasibility of Intervention Measure, a validated four-item implementation outcome instrument. Scores range from 1 to 5, with higher scores indicating greater perceived feasibility among clinicians and staff.
Measured: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
Thirty-Day Unplanned Readmission
Percentage of patients with an unplanned hospital readmission within 30 days after discharge from the index surgical hospitalization. Measured as the percentage of patients with an unplanned hospital readmission within 30 days after discharge from the index surgical hospitalization.
Measured: Within 30 days after discharge from the index surgical hospitalization.
Postoperative Complications
Percentage of patients with one or more postoperative complications after surgery, identified from electronic health record data. Measured as the percentage of patients with one or more postoperative complications within 30 days after surgery, identified from electronic health record data.
Measured: Within 30 days after surgery.
Mortality
Percentage of patients who die after surgery, identified from electronic health record data. Measured as the percentage of patients who die within 30 days after surgery, identified from electronic health record data.
Measured: Within 30 days after surgery.
Discharge Disposition
Patient discharge destination after the index surgical hospitalization, categorized as home, home with services, inpatient rehabilitation, skilled nursing facility, long-term acute care facility, hospice, or other discharge destination.Measured as the percentage of patients discharged to each destination category after the index surgical hospitalization, including home, home with services, inpatient rehabilitation, skilled nursing facility, long-term acute care facility, hospice, or other discharge destination.
Measured: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge cluster randomized implementation study. Twelve surgical oncology services are randomized into three rollout groups. Groups cross over from usual care/pre-implementation to ACS GSV implementation at prespecified time periods until all services receive the intervention.
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samilia Obeng-Gyasi, Ohio State University Comprehensive Cancer Center
- Investigators
- Samilia Obeng-Gyasi, MD, MPH, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606287
- Sponsor's protocol ID
- OSU-26031
- Other IDs
- NCI-2026-02917
- Status last verified
- Jul 2026
- First submitted
- 2 May 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study uses institutional EHR-derived clinical data, quality dashboard data, implementation data, and staff survey data that are subject to institutional privacy, IRB, and data governance restrictions. Aggregate findings will be reported publicly, and data access requests may be considered through Ohio State's institutional review and data governance processes.